Kornimate/medical-research-clean huggingface dataset:
maintenance phase treatment with divalproex for post traumatic stress disorder

Conditions: PTSD

Summary: the primary objective is to evaluate the long-term efficacy of divalproex sodium (depakote) in the continuation treatment of ptsd.

patients who have participated in the 8-week randomized, double-blind, placebo-controlled treatment trial of divalproex for ptsd and have signed informed consent will be enrolled in a 24-week open-label divalproex continuation phase trial. patients' symptoms, side effects and compliance will be assessed every two weeks for 4 weeks, then every 4 weeks, thereafter, up to 24-weeks. based on symptomology and occurrence of side effects, the investigator will titrate the medication in 500 mg (one tablet) increments every four days, as tolerated, until a maximum therapeutic benefit is achieved, not to exceed 3000 mg/day. the dosing is twice daily, with the higher dose at bedtime. compliance will be assessed by monthly pill count and valproic acid levels at the week(s) 4, 12 and 24. patients are given supportive clinical management during the clinic visits. an investigator is available by telephone 24 hrs a day in case of emergency. patients may be seen more often if needed. efficacy will be measured by the structured rating scales for depression, global function and assessment and ptsd. results of this study will be used to evaluate the long-term efficacy of divalproex in the maintenance treatment of ptsd.

Eligibility criteria:
inclusion criteria: 1. diagnosis of ptsd, confirmed by mini and caps. 2. participation in the placebo-controlled acute phase study with divalproex for ptsd 3. age 19 or older 4. no substance abuse/dependence for the previous 6 weeks (except for nicotine and caffeine) 5. clinically normal physical and laboratory examination (lab profile listed below). lfts up to 2.5 times the normal limit will be allowed. 6. women of childbearing potential must be using medically approved methods of birth control (such as a condom, birth control pill, depoprovera, or diaphragm with spermicide) 7. signed informed consent 8. male or female, any race or ethic origin exclusion criteria: 1. lifetime history of bipolar i, psychotic, or cognitive disorders 2. actively suicidal, homicidal, or psychotic 3. history of sensitivity to divalproex 4. unstable general medical conditions 5. score ≥ 6 on question #10 of madrs 6. women who are pregnant, planning to become pregnant or breastfeed during the study

Keywords: divalproex sodium, depakote, ptsd, long-term ptsd treatments
a study evaluating the effects of topical clitoral estradiol cream in post menopausal women

Conditions: Hypoactive Sexual Desire Disorder

Summary: the purpose of this research study is to learn about sexual function in postmenopausal women and to determine whether the use of topical clitoral application of estradiol improves women's libido, arousal, and orgasmic ability.


Eligibility criteria:
inclusion criteria: * sexually active postmenopausal women of any age with complaint of vulvar and/or vaginal atrophy who also complain of bothersome decreased libido, and/or arousal, and/or orgasmic dysfunction exclusion criteria: * not sexually active with a partner or an arousal device * uncontrolled diabetes as defined by having a consistent blood sugar level of over 100 mg/dl * uncontrolled hypertension as defined by an average systolic blood pressure ≥140 mmhg or an average diastolic blood pressure ≥90 mmhg, among those with hypertension * allergic to estradiol * contraindications to estradiol such as undiagnosed abnormal genital bleeding; known/suspected or history of breast cancer; known/suspected estrogen-dependent neoplasm; active deep vein thrombosis, pulmonary embolism; active or recent stroke or myocardial infarction; liver dysfunction or disease * spanish speaking

Keywords: arousal orgasm clitoral estradiol post menopausal
safety and efficacy of gx-188e dna therapeutic vaccine administered by electroporation after observation

Conditions: Cervical Intraepithelial Neoplasia 3

Summary: this study is to follow up on the change of immune response by measuring hpv type 16/18 e6 and e7 specific t cell response and lesion condition in subjects who have administered in dna-based therapeutic vaccine.

this is a follow-up study to investigate the change of immunogenicity and lesion condition in subjects with cervical intraepithelial neoplasia (cin) 3 who have enrolled and completed gx-188e phase i study. subjects will make visits at week 48 (v1) to week 228 (v8) every 6 months after the final administration of gx-188e. the endpoints are to evaluate the change of immune response, involved lesion and infection status compared to that of the final visit in phase i study.

Eligibility criteria:
inclusion criteria: * female aged between 20 and 50 (inclusive) * the subjects who have visited within 48 weeks after final injection of gx-188e * those who voluntarily signed informed consent form exclusion criteria: * prior participation in any clinical trial within 30 days prior to the visit 1 * any other ineligible condition at the discretion of the investigator that would be ineligible to participate the study

Keywords: phase 1 follow up cervical intraepithelial neoplasia adult safety efficacy
changes of optic nerve sheath diameter between obese and non-obese patients undergoing laparoscopic gynecological surgery

Conditions: Optic Nerve Sheath Diameter

Summary: this study aims to compare the change of optic nerve sheath diameter in obese and non-obese patients undergoing laparoscopic gynecological surgery in a steep trendelenburg position.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic gynecological surgery exclusion criteria: * ophthalmic diseases * previous history of ophthalmic surgery. * neurological disorders * history of head surgery.
post-placental intrauterine device insertion during cesarean section

Conditions: Intrauterine Device Migration

Summary: effective, reversible postpartum contraception decreases the chance of rapid repeat pregnancy and poor perinatal outcome in a subsequent pregnancy especially in women delivered by cesarean section.the traditional 6-week postpartum visits not evidenced based and may not meet patient needs, particularly with respect to provision of contraception.intrauterine device placement after delivery of the placenta is an appealing strategy for increasing access to postpartum intrauterine device because it does not require a separate postpartum visit. advantage of post-placental intrauterine device insertion, intrauterine devices are recommended as first-line contraceptives by the american academy of pediatricians. the centers for disease control and prevention united state . medical eligibility criteria for contraceptive use places no restrictions on use, and states advantages generally outweigh the risks for immediate postpartum use of intrauterine devices.


Eligibility criteria:
inclusion criteria: 1. age group : 18-40 years 2. women who will be willing to undergo elective cesarean section 3. women desire using copper iud as long acting contraceptive method. exclusion criteria: 1. intrauterine infection. 2. fundal myoma. 3. hemorrhagic disorder 4. genital tract malignancy 5. uterine atony 6. sexually transmitted infection.
a study of itacitinib (incb039110) in combination with ibrutinib in subjects with relapsed or refractory diffuse large b-cell lymphoma

Conditions: Lymphoma

Summary: the purpose of this study is to evaluate the safety/tolerability and efficacy of itacitinib in combination with ibrutinib in subjects with relapsed or refractory diffuse large b-cell lymphoma (dlbcl)


Eligibility criteria:
inclusion criteria: * histologically documented diagnosis of dlbcl. * phase 1: any dlbcl subtype. * phase 2: activated b-cell or unclassifiable subtypes confirmed by immunohistochemistry using the hans algorithm * relapsed or refractory dlbcl, defined as having received at least 1 but no more than 3 prior treatment regimens and ineligible for high-dose chemotherapy/autologous stem cell transplant. * fluorodeoxyglucose-avid disease (based on local evaluation) per the lugano classification. fluorodeoxyglucose-avid disease is defined as disease with a 5-point scale score of 4 or 5. * archived tumor tissue (block or 15-20 unstained slides) available, or be willing to undergo an incisional or excisional lymph node biopsy of accessible adenopathy (or, in less accessible lymph nodes, 4 to 8 core biopsies). * at least 1 measurable (≥ 2 cm in longest dimension) lesion on ct scan or magnetic resonance imaging (mri). * eastern cooperative oncology group (ecog) performance status 0 to 2. exclusion criteria: * transformed dlbcl or dlbcl with coexistent histologies (eg, follicular or mucosa-associated lymphoid tissue lymphoma). * primary mediastinal (thymic) large b-cell lymphoma. * known central nervous system lymphoma (either primary or metastatic). * allogeneic stem cell transplant within the previous 6 months, or active graft versus host disease following allogeneic transplant. * use of immunosuppressive therapy within 28 days of starting study treatment. immunosuppressive therapy includes but is not limited to cyclosporine a, tacrolimus, or high-dose corticosteroids. subjects receiving corticosteroids must be at a dose level ≤ 10 mg/day within 7 days of initiating study treatment. * prior or concurrent therapy with a janus kinase inhibitor or bruton's tyrosine kinase inhibitor

Keywords: diffuse large b-cell lymphoma relapsed diffuse large b-cell lymphoma refractory diffuse large b-cell lymphoma activated b cell germinal center b-cell non-hodgkin lymphoma jak1 inhibitor bruton's tyrosine kinase (btk) inhibitor
metabolism variability of venlafaxine

Conditions: Major Depressive Disorders

Summary: regarding the direct costs and the social value of depression, the decision of an antidepressant treatment prescription must be optimized as much as possible. the development of a personalized medicine in psychiatry may reduce treatment failure, intolerance or resistance, and hence burden and costs of affective disorders. there is hope that biomarkers will be found to guide treatment selection. it might be of decisive interest to be able to assess an individual's metabolism activity. we propose here to explore the relationship between the activity of drug-metabolizing enzymes (dme) and transporters- assessed by a phenotypic approach and the efficacy of antidepressants. we will focus on venlafaxine (v) that provides a reasonable second-step choice for patients with depression and is used extensively in psychiatric practice, and the metabolism of which involves several cytochromes (cyp) p450 enzymes and the transporter p-gp. thus, the primary objective of this study is to study the correlation between the concentration of v and its metabolite odesmethylv (v+odv) and drug metabolism variability assessed by a phenotypic approach, in patients with major depressive disorder and madrs ≥ 20 despite 4 weeks of v at 150mg or less


Eligibility criteria:
inclusion criteria: * patient (hospitalized or outpatient) with major depressive disorder and madrs ≥ 20 at visit of selection * patients non responders to v after 4 weeks of v at 150mg or less * decision of the psychiatrist to increase the dose of v at visit of selection * understanding of french language and able to give a written inform consent. * informed consent signed to participate to the study * individuals covered by social security regimen exclusion criteria: * patients treated by more than one antidepressant * patients currently treated with one of the drug substrate of the cocktail * sensitivity or contra-indication to any of the substrate drugs used * current pregnancy, desire to get pregnant, or breastfeeding * bipolar disorder and schizophrenia
study of oxaliplatin, irinotecan, and s-1 in gastric cancer

Conditions: Stomach Neoplasm

Summary: this study will conduct a phase ii study of triple combination with oxaliplatin, irinotecan, and s-1 as the first-line chemotherapy in patients with advanced gastric cancer.

it is widely accepted that the efficacy of chemotherapy for patients with inoperable, advanced, and metastatic gastric cancer is better than that compared to best supportive care. in general, combination chemotherapies are more efficient than monotherapy and so it is reasonable to give combination chemotherapy to patients with good performance status. especially dual combination chemotherapy with fluoropyrimidine and platinum has shown the objective response rate of 25-48% in patients with newly diagnosed advanced metastatic gastric cancer and several studies about triple combination with oxaliplatin, irinotecan, and fluoropyrimidine have shown the response rate of 53\~75% but also higher rate of hematologic adverse events. so the investigators had conducted the phase i study of these three drugs with modification of dosage and schedule and will conduct a phase ii study with recommended dose of triple chemotherapy from this phase i study.

Eligibility criteria:
inclusion criteria: * pathologically confirmed advanced, recurrent or metastatic adenocarcinoma of stomach (stage iv by primary tumor, regional nodes, metastasis(tnm) staging system) * eastern cooperative oncology group (ecog) performance status 0-2 * more than 3 months expected life span * measurable lesion by recist criteria version 1.1 * palliative chemotherapy naive * adequate organ functions * participants must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital exclusion criteria: * positive her2 status on participants' cancer tissue. * any prior 2 years or concurrent malignancy other than non-melanoma skin cancer, in situ cancer of uterine cervix, or papillary or follicular thyroid cancer. * participants who had received radiation therapy for target lesions 4 weeks before study enrollment * participants who had received major surgery 4 weeks before study enrollment * participants with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 12 months, pregnancy, or breast feeding * participants with central nervous system(cns) metastases * participants with peripheral sensory neuropathies with impaired functional activities * participants with gastrointestinal obstruction or bleeding inducing mal-absorption of oral chemotherapeutic agents.

Keywords: stomach neoplasm oxaliplatin irinotecan s-1
effect of two preventive exercise programs for swimmer's shoulder on the torque of shoulder rotator muscles in competitive swimmers

Conditions: Shoulder Pain; Injury;Sports; Sports Physical Therapy

Summary: the purpose of this study was to verify the effectiveness of two 12-week preventive exercise programs for swimmer's shoulder with monitoring and progression over time, on the peak torque and respective conventional concentric ratio and functional ratio. one of these programs was performed with weights and the other with an elastic band. this study hypothesized that the two preventive exercise programs minimize shoulder rotators imbalanced during the swimming season. the study design is a care provider and participants blinded, parallel, randomized controlled trial


Eligibility criteria:
inclusion criteria: * competitve swimmer in the current season. * aged between 16-35 years old. * have a minimum of 5 years of experience in national competitions. * performed a minimum of 8 hours of weekly swimming training. exclusion criteria: * subjects who had performed at least 6 weeks of treatment such as physical therapy, injections, and medication. * clinical situations such as a history of significant shoulder pain in the last 6 months, a history of traumatic shoulder injuries such as fractures, subluxations, cervical or thoracic conditions, previous shoulder surgeries, shoulder range of motion deficits, or neurological injuries.

Keywords: swimmer's shoulder elastic band program weight program shoulder rotators injury prevention swimming
68ga-fapi pet/ct in pancreatic ductal carcinoma

Conditions: PDAC

Summary: fibroblast activation protein (fap) is overexpressed in cancer-associated fibroblasts (cafs), which constitutes a major proportion of cells within the tumor microenvironment, especially in primary pancreatic ductal carcinoma (pdac). in this prospective study, we aimed to evaluate the performance and value of 68ga-fapi-04 pet/ct in the patients with pdac.

with an incidence rate of 10 cases per 100,000 people per year, cancer of the pancreas is the third most common malignancy of the gastrointestinal tract. the overall survival for patients with pancreatic cancer is very poor, with a 5-year survival of 1% to 4%. successful therapy depends on early diagnosis. the discrimination between benign and malignancies of the pancreas and the assessment of local resectability and distant metastases of the pancreatic cancer remains challenging with different imaging modalities such as ultrasound (us), endoscopic us (eus), multidetector row computed tomography (mdct), magnetic resonance imaging (mri), and 18f-fdg positron emission tomography (pet). pdac is characterized by a distinct and exuberant desmoplastic stroma, with stromal components outnumbering the pancreatic cancer cells. in pdac, more than 90% of the tumour volume consists of cancer-associated fibroblasts (caf). fibroblast activation protein (fap) is highly and selectively expressed in cafs but is weakly expressed or not detected in normal tissues. the aim of this study was to evaluate the impact of fapi-pet/ct on the clinical management of patients with suspected pancreatic cancer.

Eligibility criteria:
inclusion criteria: 1. patients with suspected pancreatic lesions 2. signed written consent. exclusion criteria: 1. pregnancy; 2. breastfeeding; 3. any medical condition that in the opinion of the investigator may significantly interfere with study compliance
copeptin and psychological stress of medic during covid-19 pandemic

Conditions: Psychological Stress; Hemostatic Disorder

Summary: psychological stress (pss) is one of the most common problems among healthcare providers during covid-19 pandemic. pss influences the homeostatic equilibrium of the body, involving activation of the sympathetic nervous system and hypothalamus pituitary adrenal (hpa) axis. copeptin; c-terminal portion of vasopressin (avp) precursor is stable. nevertheless, evidence about influence of pss on copeptin levels is lacking. the reason we are doing this research is to determine the level of psychological stress among healthcare providers exposed to at the time of work in intensive care unit (icu) during covid-19 pandemic; they will be appraised every assembly for psychological stress level; before start of duty shifts (first time), one week after start (second time) and two weeks after departure from shift duties in icu (third time) for assessment of psychological stress level and stress hormones.

a total of 70 healthcare personnel volunteers participated; 35 physicians and 35 nurses. all healthcare providers' volunteers are in good physical health, exclusion criteria included hypertension, diabetes mellitus, obesity bmi ≥30, subjects with serum sodium ≤135 or ≥ 145 mmol /l at baseline or females receiving contraceptive pills. during the research participants will answer a questionnaire as well as three blood samples are taken. * in the first meeting, evaluation of participant general condition; determining bmi, blood pressure. then a small amount of blood, equal to about two millimeters, will be taken from participant arm with a syringe. this blood will be tested for serum copeptin, cortisol (fasting morning sample). the investigator will ask participant few questions to evaluate the level of stress (as anxiety, insomnia, fear of infection through questionnaire) * the second meeting, one week after work in icu, another blood sample will be taken from participant and determine level of psychological stress. * the third meeting, two weeks after leave from icu participant blood sample will be taken from participant to determine stress hormones and determine level of psychological stress. duration the research takes place over six months in total.

Eligibility criteria:
inclusion criteria: physicians and nurses under age of 37 years in good health exclusion criteria: * body mass index above 30 * hypertension * diabetes mellitus * females receiving contraceptive pills

Keywords: psychological stress copeptin hormones
comparison between infliximab and adalimumab on patients with ulcerative colitis

Conditions: Ulcerative Colitis; Inflammatory Bowel Diseases

Summary: anti-tnf (tumor necrosing factor) treatment with infliximab (ifx) and adalimumab (ada) are established first-line biological therapies used in treatment of patients with ulcerative colitis (uc). there are no head-to-head comparative studies between these two drug but meta-analysis of randomized controlled trials states that ifx might be more effective than ada for the induction of clinical remission. however, several observational studies conclude that ada seem to have similar effect as ifx in treating patients with uc but these studies have limitations. the overall aim of this retrospective multicenter observational cohort study is to evaluate if there is a difference in efficacy between infliximab (ifx) and adalimumab (ada) in treating bio-naive patients with uc in the short and long term during the modern era when therapeutic drug monitoring have been used to optimize anti-tnf treatment.


Eligibility criteria:
inclusion criteria: * age 18-100 years. * diagnosis of ulcerative colitis confirmed by endoscopy and histology. * mild, moderate and severe disease activity. * initiation of ifx or ada-treatment at one of the centers of the study. exclusion criteria: * clinical remission. * previous colonic surgery (resection of colonic segment or colectomy). * primary indication for anti-tnf therapy by other disease than uc. * prior use of any anti-tnf or other biologic or small molecule therapy. * rescue therapy (i.e. infliximab used on hospitalized patients receiving intravenous corticosteroids).

Keywords: infliximab adalimumab anti-tnf therapy
online, gut-directed hypnotherapy for patients with irritable bowel syndrome (ibs)

Conditions: IBS - Irritable Bowel Syndrome

Summary: adult ibs patients with symptoms refractory to standard medical treatment will receive online nurse-administered, gut-directed hypnotherapy in groups. the primary outcome measure was change in gastro-intestinal symptom severity.

ibs patients with symptoms refractory to standard treatment and who were referred to a specialist unit for hypnotherapy, will be included in the study consecutively. the patients will receive gut-directed hypnotherapy given by a nurse trained in cognitive behavioral therapy (cbt) and hypnotherapy. effects of treatment will be measured by validated questionnaires at baseline and at various time points during the treatment period, as well as after the completion of the treatment at follow-up 6 months, 1 and 2 years after treatment.

Eligibility criteria:
inclusion criteria: * ibs diagnosis exclusion criteria: * organic gi disease

Keywords: gut-directed hypnotherapy